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Abbott Medical Electronics Co.

USA · Fort Worth
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada — 4 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
75listed device types
Class I 11Class II 32Class III 32
plus 292 registration records and 61 510(k), 3,584 PMA
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
35registered devices
Class I 15Class II 20
227 including historic records
SASaudi ArabiaSFDA
5registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
12active device licences
Class II 10Class III 1Class IV 1
239 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
pendingnot queried
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States292 registration records, 61 510(k), 3,584 PMA, 63 excluded
Brazil35 confirmed, 29 excluded
Saudi Arabia5 confirmed, 1 excluded
Canada12 confirmed, 30 excluded
Manufacturer names merged into this page: Abbott Medical · ABBOTT MEDICAL
Same-named companies — This database also contains companies with near-identical names: Abbott Medical Optics, Inc.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Fort Worth

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

11979
11980
42019
42020
52021
82022
102023
82024
132025
72026

FDA listed device types

showing 8 of 75
Sizer, Heart-Valve, Prosthesis 1Instrument, Surgical, Disposable 1Holder, Heart-Valve, Prosthesis 1Magnet, Test, Pacemaker 1Tools, Pacemaker Service 1Tape, Measuring, Rulers And Calipers 1Cardiovascular Delivery Catheter System Positioning And Stabilization Device 1Medical Device Data System 1

Registration details (sample)

MarketIdentifierNameClass / date
USK262006EnSite™ X EP System2026-07-15
USK261631Amplatzer TorqVue Exchange System2026-06-17
USK253459OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)2026-04-24
BR10332340471Electrophysiology CableClass I
BR10332340414Cabo Adaptador NeuroTherm™Class I
BR10332340500Agilis HisPro SlitterClass I
SAME0000014762SFDAA00006Lift—
SAME0000014762SFDAA00004Stabilizer—
CA1345FAST-CATH(TM) HEMOSTASIS INTRODUCERSClass II
CA27298ULTIMUM HEMOSTASIS INTRODUCERClass II
CA69836ABBOTT MEDICAL VESSEL DILATORSClass II

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